Aderis Pharmaceuticals’ Phase II Atrial Fibrillation Data Accepted For American Heart Association 2003 Scientific Sessions
Aderis Pharmaceuticals announced today that data from a Phase II clinical trial of selodenoson (formerly DTI-0009) for the treatment of atrial fibrillation will be presented at the American Heart Association’s 2003 Scientific Sessions. Selodenoson is a selective adenosine A1 receptor agonist being developed in conjunction with Fujisawa Healthcare, Inc. as an agent to control heart rate during atrial fibrillation. Atrial fibrillation is a common arrhythmia that can result in an abnormally fast heart rate. This condition affects more than 2 million Americans and 6 million people worldwide.“We are excited about the opportunity to present our Phase II selodenoson data during this international conference,” said William Wheeler, M.D., FACC, Vice President and Chief Medical Officer of Aderis Pharmaceuticals. “We are pleased with selodenoson’s progress in clinical trials, as well as the recent progress of our other late-stage development programs. These programs include rotigotine-CDS, partnered with Schwarz Pharma AG, which is completing Phase III trials for Parkinson’s disease and is in Phase IIb trials for Restless Legs Syndrome. In addition, binodenoson recently completed Phase II trials as a pharmacologic stress agent for the diagnosis of coronary artery disease and is partnered with King Pharmaceuticals.”
The abstract, entitled “Intravenous Selodenoson (Formerly DTI-0009), A Novel Adenosine A1 Agonist, Acutely Controls Ventricular Rate in Atrial Fibrillation Without Significant Hemodynamic Consequences,” will be presented by Brent T. McLaurin, M.D., of Carolina Cardiology Consultants on Monday, November 10, 2003 at 3:00 PM (EST). The American Heart Association’s Scientific Sessions is the world’s largest gathering of scientists and healthcare professionals dedicated to the study and treatment of cardiovascular disease and stroke. The 2003 convention will take place November 9-12 in Orlando, Florida.
Selodenoson, an adenosine A1 agonist, is being developed as an intravenous formulation for the acute treatment of atrial fibrillation in a hospital setting, as well as an oral formulation for chronic management of the disease. Using its small molecule development expertise, Aderis Pharmaceuticals designed selodenoson to control heart rate through selective adenosine A1 receptor stimulation. Selodenoson reduces heart rate in patients without lowering blood pressure, a common complication with current rate control treatments.
Aderis licensed to Fujisawa the U.S. and Canadian development and commercialization rights to intravenous selodenoson. In March 2003, Aderis announced the receipt of a $2 million milestone payment from Fujisawa in connection with the completion of an earlier Phase II intravenous selodenoson clinical trial done by Fujisawa.
Background:
Atrial fibrillation is the most common sustained arrhythmia and is increasing in incidence due to both an aging population and an increase in patients with underlying conditions that can predispose them to atrial fibrillation, such as congestive heart failure. Atrial fibrillation results in rapid and irregular heart rates of up to 120-180 beats/minute – 2 to 3 times faster than a normally functioning heart. At this rate, the heart cannot effectively pump blood to the rest of the body, causing symptoms ranging from shortness of breath to heart failure.
About Aderis Pharmaceuticals
Aderis Pharmaceuticals is a private, biopharmaceutical company engaged in small molecule drug development to treat central nervous system, cardiovascular and inflammatory conditions. The Company’s product pipeline includes small molecule, receptor agonists and antagonists for the treatment of Parkinson’s disease, Restless Legs Syndrome, atrial fibrillation, diabetic foot ulcers, the diagnosis and prognosis of coronary artery disease, and other cardiovascular and inflammatory conditions. Aderis and its partners currently have four product candidates in development for six indications. Aderis Pharmaceuticals has a strategic alliance with Schwarz Pharma AG, for the development and commercialization of rotigotine-CDS, a proprietary dopamine agonist formulated as a once-a-day, continuous delivery, transdermal patch. Rotigotine-CDS is currently completing Phase III clinical trials for Parkinson’s disease and is in a Phase IIb clinical trial for the treatment of Restless Legs Syndrome. The Company also has alliances with Fujisawa Healthcare, Inc. and King Pharmaceuticals. Founded in 1994, Aderis Pharmaceuticals is headquartered in Hopkinton, Massachusetts and has research facilities in Richmond, Virginia.
Certain statements in this news release that are not historical fact constitute “forward-looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results of Aderis Pharmaceuticals to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Such statements include, but are not limited to, any statements relating to the Company’s development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties, including but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company’s drug candidates; unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug candidates that could slow or prevent product development or commercialization; the uncertainty of patent protection for the Company’s intellectual property or trade secrets; and the Company’s ability to obtain additional financing if necessary. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors, some but not all of which may have been mentioned above.
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